To observe the efficacy and toxicities of heavy ion radiation therapy for locally advanced or advanced primary thymic epithelial malignant tumor received R2 resection. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was local relapse-free survival, overall survival and cause-specific survival.
The patients will receive 72GyE per 18 fractions of carbon ion radiotherapy. Patients with thymus cancer should be combined with platinum-based regimen (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin; paclitaxel combined with cisplatin or cisplatin / carboplatin / loplatin / nedaplatin; docetaxel combined with cisplatin / carboplatin / loplatin / nedaplatin) for at least 4 cycles. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was local relapse-free survival, overall survival and cause-specific survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
The patients will receive 72GyE per 18 fractions of carbon ion radiotherapy. Patients with thymus cancer should be combined with platinum-based regimen (including etoposide combined with cisplatin / carboplatin / loplatin / nedaplatin; paclitaxel combined with cisplatin or cisplatin / carboplatin / loplatin / nedaplatin; docetaxel combined with cisplatin / carboplatin / loplatin / nedaplatin) for at least 4 cycles. The primary endpoint was progression-free survival and toxicities, and the secondary endpoint was local relapse-free survival, overall survival and cause-specific survival.
combined with platinum-based regimen
Shanghai Proton and Heavy Ion Center
Shanghai, Shanghai Municipality, China
RECRUITINGDisease progression-free survival rate
Disease progression-free survival rate was defined from the start of carbon ion radiotherapy till the date of disease progression at any site or death, or the last follow up.
Time frame: From date of radiotherapy started until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Incidence of Treatment-induced Adverse Events
Treatment-induced toxicities were scored using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, for events observed after the first dose of irradiation. Toxicities occurred 90 or more days after the completion of CIRT were defined as late toxicities.
Time frame: From date of radiotherapy started, every 3-4 months within the first 2 years, every 6 months between years 3 and 5, and annually thereafter, assessed up to 100 months.
Local-progression free survival rate
Local-progression free survival rate was defined from the start of carbon ion radiotherapy till the date of local progression or the last follow-up.
Time frame: From date of radiotherapy started until the date of first documented local disease progression, assessed up to 100 months.
Overall survival rate
Overall survival rate was defined from the start of carbon ion radiotherapy till the date of death or the last follow-up.
Time frame: From date of radiotherapy started until the date of death from any cause, assessed up to 100 months.
Cause-specific survival rate
Cause-specific survival rate was defined from the start of carbon ion radiotherapy till the date of death caused by thymus tumor treated in this study or the last follow-up.
Time frame: From date of radiotherapy started until the date of death caused by thymus tumor treated in this study , assessed up to 100 months.
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